Vaccine for the prevention of diphtheria, pertussis, poliomyelitis, tetanus and infections caused by Haemophilus influenzae type b (Vaccine for the prevention of diphtheria, pertussis, poliomyelitis, tetanus and infections caused by Haemophilus influenzae type b)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Vaccines, serums, phages and toxoids

Included in the formulation
Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

VED

АТХ:

J.07.C.A.06   Vaccine against diphtheria, Haemophilus influenzae B, pertussis, poliomyelitis, tetanus

J.07.C.A   Combination of vaccines for the prevention of viral and bacterial infections

Pharmacodynamics:

The antigenic activity of vaccine components does not differ from the antigenic activity of the corresponding monovaccines.

Since the immune response to pertussis antigens in the vaccine is equivalent to that of pertussis antigens in the vaccine, it is expected that the protective efficacy of the two vaccines will be similar.

Protective efficacy against whooping cough in the vaccine was defined as ≥21 days of paroxysmal cough (WHO definition). A prospective study in Germany (secondary household contacts) demonstrated protective efficacy at 88.7%.

Effective against infection caused by Haemophilus influenza type b, was evaluated in a post-marketing study in Germany and was 89.6% for those who received the primary vaccination course and 100% for those who received the primary course of vaccination and revaccination.

Pharmacokinetics:

No data.

Indications:

Primary vaccination and revaccination of children against diphtheria, tetanus, pertussis, poliomyelitis and infection caused by Haemophilus influenza type b.

ICD-10

XXI.Z20-Z29.Z27.8   The need for immunization against other combinations of infectious diseases

Contraindications:

- hypersensitivity to the active ingredients of the vaccine or to any of the components of the vaccine, as well as to neomycin and polymyxin;

- hypersensitivity after previous administration of diphtheria, tetanus, pertussis vaccines, polio vaccine or vaccine to prevent infection caused by Haemophilus influenzae type b;

- encephalopathy of unclear etiology that developed within 7 days after the previous administration of a vaccine containing a pertussis component. In this case, the administration of pertussis vaccine should be discontinued, and vaccination should continue with diphtheria-tetanus vaccine alone, and with a vaccine to prevent infection caused by pertussis. Haemophilus influenza type b;

- acute infectious and non-infectious diseases, exacerbations of chronic diseases are temporary contraindications for vaccination.Scheduled vaccinations are carried out 2-4 weeks after recovery or during the period of convalescence or remission. With mild ARVI, acute intestinal diseases and other vaccinations are carried out immediately after the normalization of temperature.

Carefully:

The vaccine should be used with caution in patients with thrombocytopenia or with blood coagulation disorders, since intramuscular injection can cause bleeding in these patients.

Pregnancy and lactation:

Since the vaccine is used in accordance with the National Calendar of preventive vaccinations of the Russian Federation in children, there is no evidence of the effect of the drug on the course of pregnancy and lactation.

Dosing and Administration:

Vaccination schedule

A single dose of the vaccine is 0.5 ml.

Primary vaccination:

According to the National calendar of preventive vaccinations of the Russian Federation, the course of primary vaccination consists of three doses of the vaccine administered at 3; 4,5 and 6 months. However, other three-dose regimens (for example 2-3-4 months, 3-4-5 months, 2-4-6 months) and a two-dose (eg 3-5 months) primary vaccination can also be used on the recommendation of a doctor.It is necessary to observe the interval between doses not less than 1 month.

Revaccination

According to the National calendar of preventive vaccinations of the Russian Federation, revaccination is performed once in 18 months of life.

Nevertheless, on the recommendation of a doctor, a revaccination can be performed at another time if the interval is observed not less than 6 months after the last inoculation of the primary course. Thus, after a two-dose primary vaccination (eg 3-5 months), the booster dose is preferably administered between 11 and 13 months of life, after a three-year course of primary immunization, a revaccinating dose can be administered up to 18 months.

In all cases of violation of the vaccination schedule, the physician should be guided by the instruction for the use of the drug and the recommendations of the National calendar of preventive vaccinations of the Russian Federation.

Method of administration

The recommended insertion site is the middle third of the anterolateral surface of the femur. The vaccine should be administered intramuscularly, alternating sides with subsequent injections.

Under no circumstances should the vaccine be administered intravenously or intradermally.

The syringe containing the vaccine should be shaken to obtain a homogenous homogeneous suspension of whitish color.

The vaccine should be visually checked for lack of mechanical inclusions and / or change in appearance. If they are detected, the use of the vaccine should be discarded.

For a two-needle package option, before removing the vaccine from the nozzle of the syringe, the protective rubber cap must be removed and the sterile needle in a separate plastic container tightly fixed to the syringe.

To restore the vaccine, you must remove the protective plastic lid and the aluminum cap from the vial containing the lyophilizate. Then introduce the suspension contained in the syringe (vaccine for the prevention of diphtheria, tetanus, pertussis and poliomyelitis) through the needle into the vial with lyophilizate (vaccine to prevent infection caused by Haemophilus influenzae type b) by piercing the needle with a rubber vial plug. Enter the content completely. Without disconnecting the syringe from the vial, it is necessary to wait for the complete dissolution of the lyophilizate (no more than 5 minutes).

The reconstituted vaccine is a more turbid suspension compared to the original vaccine used for reconstitution. In case of other changes, the vaccine must be destroyed.After restoration, the vaccine must be completely recruited into the syringe, replaced with a needle and promptly injected. In this case, the reconstituted vaccine can be at room temperature (21 ° C) for 8 hours.

Preferably, the vaccine is administered after it has warmed to room temperature. In addition, at room temperature, the necessary elasticity of the vial of the vial is ensured. To do this, the bottle must be left at room temperature (25 ± 3 ° C) for five minutes before adding the suspension from the syringe. The vaccine is not used in children older than 36 months.

Side effects:

General reactions

Very often: anxiety, unusual crying, irritability, loss of appetite, fever ≥ 38 °C, fatigue.

Often: excitability, fever ≥ 39.5 ° C.

Infrequently: drowsiness.

Very rarely: convulsions (with or without fever).

From the respiratory system

Infrequent: infections of the upper respiratory tract, cough.

Rarely: bronchitis.

From the gastrointestinal tract

Often: vomiting, diarrhea.

From the skin and RVK

Often: itching.

Rarely: rash.

Very rarely: dermatitis, urticaria.

Reactions at the site of administration

Very often: soreness, redness, swelling at the injection site (≤ 50 mm).

Often: edema at the injection site (> 50 mm), seal at the injection site.

Infrequent: diffuse swelling of the extremity into which the injection was made, sometimes involving the adjacent joint.

Overdose:

Cases of overdose are not described.

Interaction:

So far, there is insufficient data on the effectiveness and safety of the simultaneous use of the vaccine and the vaccine against measles, mumps and rubella, which does not allow us to offer any recommendations on their joint application.

Data on combined use with Prevenar vaccine (adsorbed conjugated pneumococcal vaccine) showed no clinically significant change in the production of antibodies against each of the antigens that make up the vaccines when administered as a three-dose primary vaccination regimen.

However, a higher incidence of fever (> 39.5 ° C) was reported in children who received Prevenar at the same time as children who received only the vaccine.

In this case, antipyretic therapy should be started in accordance with local recommendations.

As with other vaccines, it can be expected that in patients receiving immunosuppressive therapy,an adequate immune response may not be achieved.

The vaccine should not be mixed with other vaccines in the same syringe.

Special instructions:

Before vaccination, the history of the child should be studied, paying attention to the previous administration of vaccines and the associated occurrence of adverse reactions, as well as to conduct an examination.

As with any other vaccine, you should have everything you need ready to stop a possible anaphylactic reaction to the vaccine. The vaccinated should be under medical supervision for 30 minutes after immunization.

The emergence of the following reactions after administration of the vaccine is not a contraindication for subsequent vaccinations, but the benefit / risk ratio should be taken into account:

- temperature ≥ 40 ° C, which occurred within 48 hours;

- a collapse or shock-like condition that developed within 48 hours after the introduction of the vaccine;

- a shrill scream lasting 3 hours or more, which occurred within 48 hours after the introduction of the vaccine;

- febrile or afefrilnye convulsions that occurred within 3 days after vaccination.

As with any other vaccination, not all vaccinees may have a protective immune response.

The vaccine does not prevent the development of diseases caused by any other pathogens, with the exception of Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus 1, 2, 3 types and Haemophilus influenzae type b.

There are limited data based on the vaccination of 169 premature infants, indicating that the vaccine can be given to premature infants. However, they may have a lower immune response.

HIV infection is not a contraindication to vaccination. However, after vaccination in patients with immunodeficiency, the expected immunological response may also not be achieved.

Since the capsular polysaccharide antigen Haemophilus influenzae Excreted in the urine, within 1-2 weeks after vaccination, a positive test can be recorded in the urinalysis. During this period, other tests are needed to confirm the diagnosis of the infection caused by Haemophilus influenzae type b.

In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy, vaccination against whooping cough (both whole cell and acellular vaccines) should be postponed until the condition stabilizes.The decision to prescribe a vaccine with a pertussis component should be taken individually after a thorough assessment of the benefits and risks.

It is necessary to take into account the potential risk of apnea and the need to monitor respiratory function for 72 hours with primary vaccination of children born prematurely (≤ 28 weeks gestation) and especially children with respiratory distress syndrome. In view of the need to vaccinate children of this group, the primary vaccination should not be postponed or refused. The primary course of vaccination for such children should be carried out in a hospital under the supervision of a doctor for 72 hours.

After vaccination, or sometimes in front of it, fainting or severe weakness is possible as a psychological reaction to injection. Before vaccination it is important to make sure that the patient does not get injured in the event of a syncope.

The presence of febrile seizures in the anamnesis, as well as seizures in the family history or the syndrome of sudden child death is not a contraindication, but requires special attention. Such vaccinated should be observed within 2-3 days, since during this period an undesirable phenomenon may occur.

Instructions
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